Post-Market Compliance Specialist III- Autoimmunity

Post-Market Compliance Specialist III
- Autoimmunity

Country

United States

Shift

1st

Werfen is a growing, family‑owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

The Post-Market Compliance Specialist III supports product complaint management as well as post‑market surveillance and reporting for in‑vitro diagnostic (IVD) products. Responsibilities include complaint intake for complex issues, regulatory reportability, technical investigation, laboratory testing, issue risk assessment, documentation and communication with customers and Affiliates for IVD assays and systems. The position is responsible for Post‑Market Surveillance, Device Reporting, and Field Action activities.

The role collaborates with other internal teams and global affiliates and contributes to process improvements. The role provides subject matter expertise in technical and customer relationship management to junior members of the team.

Key Accountabilities

• Complaint Management: intakes, assesses for regulatory reportability, and triages assigned complaints. Designs and executes complex experiments and performs complex complaint investigations including investigation approach determination, experimental design, testing, analyses, and resolution. Triages investigations to other internal departments or manufacturers as needed and follows up with the escalated parties until complaint resolution. Communicates throughout the complaint investigation process from intake to final resolution with customers, affiliates, and internal stakeholders.
  
  Presents product issues which should potentially be brought to the Quality Review Board or Field Action Board to PMC management. Prepares presentations and presents issues to QRB and FARB.
• Laboratory Organization: maintains laboratory cleanliness and organization. Performs routine cleaning and complete required documentation. Monitors and maintains inventory levels of laboratory test samples, consumables, reagents, and other materials. Ensures laboratory equipment and tools maintenance, calibration, service, and software versions are current.
• Tracking and Trending: conducts complaint trend analyses and coordinates the preparation of post‑market surveillance (PMS) reports. Prepares Management Review slides on PMS for department management.
• Field Actions: authors field action assessments and ensures completion of Health Hazard Evaluations (HHE/HHA) and leads recalls, Field Safety Corrective Actions (FSCAs), Field Safety Notices (FSNs), and associated regulatory notifications.
• Reportable Events: completes, files and follows up on reportable events to regulatory authorities.
• Department Procedures: assists in drafting, implementing, and maintaining departmental procedures, work instructions, and templates.
• Provides technical guidance and mentoring to junior staff. In consultation with department management, develops and executes training for new and developing staff.
• Complies with applicable standard operating procedures, applicable standards and regulations, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies.
• Demonstrates Werfen values through the quality of work and professional working relationships.
• Other duties as assigned.

Networking/Key relationships

• Marketing and…